Butalbital Compound

Pronunciation

Generic Name: aspirin, butalbital, and caffeine (AS pir in, byoo TAL bi tal, KAF een)
Brand Name: Butalbital Compound, Fiorinal

What is Butalbital Compound (aspirin, butalbital, and caffeine)?

Aspirin is a pain reliever, as well as an anti-inflammatory and a fever reducer.

Butalbital is a barbiturate. It relaxes muscle contractions involved in a tension headache.

Caffeine is a central nervous system stimulant. It relaxes muscle contractions in blood vessels to improve blood flow.

The combination of aspirin, butalbital, and caffeine is used to treat tension headaches. This medicine is not for treating headaches that come and go.

Aspirin, butalbital, and caffeine may also be used for purposes other than those listed in this medication guide.

What is the most important information I should know about Butalbital Compound (aspirin, butalbital, and caffeine)?

Do not use this medication if you have used an MAO inhibitor such as furazolidone (Furoxone), isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam, Zelapar), or tranylcypromine (Parnate) in the last 14 days. A dangerous drug interaction could occur, leading to serious side effects.

Stop using this medication and call your doctor at once if you have any symptoms of bleeding in your stomach or intestines. Symptoms include black, bloody, or tarry stools, and coughing up blood or vomit that looks like coffee grounds.

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Do not drink alcohol while you are using this medication. Alcohol may increase your risk of stomach bleeding. Dangerous side effects or death can occur when alcohol is combined with butalbital.

Butalbital may be habit-forming and should be used only by the person for whom it was prescribed. Keep this medication in a secure place where others cannot get to it.

Aspirin should not be given to a child or teenager who has a fever, especially if the child also has flu symptoms or chicken pox. Aspirin can cause a serious and sometimes fatal condition called Reye's syndrome in children.

What should I discuss with my healthcare provider before taking Butalbital Compound (aspirin, butalbital, and caffeine)?

You should not use this medication if you are allergic to aspirin, butalbital, or caffeine, or if you have:

  • stomach ulcer;

  • severe liver disease;

  • nasal polyps;

  • porphyria (a genetic enzyme disorder that causes symptoms affecting the skin or nervous system);

  • a bleeding or blood clotting disorder (such as hemophilia); or

  • an allergy to an NSAID (non-steroidal anti-inflammatory drug) such as Advil, Motrin, Aleve, Celebrex, Orudis, Indocin, Lodine, Voltaren, Toradol, Mobic, Relafen, Feldene, and others.

Do not use aspirin, butalbital, and caffeine if you have used an MAO inhibitor such as furazolidone (Furoxone), isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam, Zelapar), or tranylcypromine (Parnate) in the last 14 days. A dangerous drug interaction could occur, leading to serious side effects.

To make sure you can safely take aspirin, butalbital, and caffeine, tell your doctor if you have any of these other conditions:

  • liver or kidney disease;

  • asthma or another respiratory disease;

  • fluid retention;

  • heart disease, congestive heart failure, high blood pressure;

  • a history of head injury or brain tumor;

  • a stomach or intestinal disorder;

  • a thyroid disorder;

  • enlarged prostate or urination problems; or

  • Addison's disease (an adrenal gland disorder).

Butalbital may be habit forming and should be used only by the person for whom it was prescribed. Never share this medication with another person, especially someone with a history of drug abuse or addiction. Keep the medication in a place where others cannot get to it.

FDA pregnancy category C. Butalbital may cause addiction or withdrawal symptoms in a newborn if the mother takes the medication during pregnancy. Taking aspirin during late pregnancy may cause bleeding in the mother or the baby during delivery. Tell your doctor if you are pregnant or plan to become pregnant while using this medication.

Aspirin, butalbital, and caffeine can pass into breast milk and may harm a nursing baby. You should not breast-feed while you are using aspirin, butalbital, and caffeine.

Aspirin should not be given to a child or teenager who has a fever, especially if the child also has flu symptoms or chicken pox. Aspirin can cause a serious and sometimes fatal condition called Reye's syndrome in children.

Serious side effects may be more likely in older adults and those who are ill or debilitated.

How should I take Butalbital Compound (aspirin, butalbital, and caffeine)?

Take exactly as prescribed. Never take this medication in larger amounts, or for longer than recommended by your doctor. Follow the directions on your prescription label. Tell your doctor if the medicine seems to stop working as well in relieving your headache.

Do not stop using this medication suddenly after long-term use, or you could have unpleasant withdrawal symptoms. Ask your doctor how to avoid withdrawal symptoms when you stop using the medication.

If you need surgery, tell the surgeon ahead of time that you are using this medication. You may need to stop using the medicine for a short time.

Store at room temperature away from moisture and heat. Keep track of the amount of medicine used from each new bottle. Butalbital is a drug of abuse and you should be aware if anyone is using your medicine improperly or without a prescription.

What happens if I miss a dose?

Since this medication is taken as needed, you may not be on a dosing schedule. If you are taking the medication regularly, take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. An overdose of butalbital can be fatal.

Overdose symptoms may include extreme drowsiness, confusion, restless feeling, insomnia, tremors, fast heart rate, vomiting, stomach pain, rapid breathing, feeling hot, ringing in your ears, weak or shallow breathing, seizure (convulsions), or fainting.

What should I avoid while taking Butalbital Compound (aspirin, butalbital, and caffeine)?

This medication may impair your thinking or reactions. Avoid driving or operating machinery until you know how the medicine will affect you.

Ask a doctor or pharmacist before using any cough, cold, allergy, or pain medication. Aspirin and caffeine are contained in many combination medicines. Taking certain products together can cause you to get too much of a certain drug. Check the label to see if a medicine contains aspirin or caffeine.

Do not drink alcohol while you are using this medication. Alcohol may increase your risk of stomach bleeding. Dangerous side effects or death can occur when alcohol is combined with butalbital.

Butalbital Compound (aspirin, butalbital, and caffeine) side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Stop using this medication and call your doctor at once if you have a serious side effect such as:

  • shallow breathing, slow heart rate;

  • fast or pounding heart rate, muscle twitching;

  • confusion, unusual thoughts or behavior;

  • bloody or tarry stools, coughing up blood or vomit that looks like coffee grounds;

  • problems with urination; or

  • easy bruising, unusual bleeding (nose, mouth, vagina, or rectum), purple or red pinpoint spots under your skin.

Less serious side effects include:

  • drowsiness, dizziness;

  • mild nausea, gas, upset stomach, stomach pain; or

  • sleep problems (insomnia).

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

See also: Side effects (in more detail)

What other drugs will affect Butalbital Compound (aspirin, butalbital, and caffeine)?

Before using this medication, tell your doctor if you regularly use other medicines that make you sleepy (such as cold or allergy medicine, sedatives, narcotic pain medicine, sleeping pills, muscle relaxers, and medicine for seizures, depression, or anxiety). They can add to sleepiness caused by butalbital.

Tell your doctor about all other medicines you use, especially:

  • insulin or oral diabetes medication;

  • mercaptopurine (Purinethol);

  • methotrexate (Rheumatrex, Trexall);

  • probenecid (Benemid);

  • a blood thinner such as warfarin (Coumadin, Jantoven);

  • an antidepressant such as citalopram (Celexa), escitalopram (Lexapro), fluoxetine (Prozac, Rapiflux, Sarafem, Selfemra, Symbyax), fluvoxamine (Luvox), paroxetine (Paxil, Pexeva), sertraline (Zoloft), trazodone (Desyrel, Oleptro), or vilazodone (Viibryd);

  • another barbiturate such as butabarbital (Butisol), secobarbital (Seconal), pentobarbital (Nembutal), or phenobarbital (Solfoton);

  • an NSAID such as ibuprofen (Advil, Motrin), naproxen (Aleve, Naprosyn, Naprelan, Treximet), celecoxib (Celebrex), diclofenac (Arthrotec, Cambia, Cataflam, Voltaren, Flector Patch, Pennsaid, Solareze), indomethacin (Indocin), meloxicam (Mobic), and others;

  • another salicylate such as Nuprin Backache Caplet, Kaopectate, KneeRelief, Pamprin Cramp Formula, Pepto-Bismol, Tricosal, Trilisate, and others; or

  • steroid medication such as prednisone (Deltasone, Sterapred), methylprednisolone (Medrol), fluticasone (Advair, Flonase, Flovent, Veramyst), beclomethasone (Qvar), budesonide (Pulmicort, Rhinocort, Symbicort), dexamethasone (Cortastat, Dexasone, Solurex, DexPak), mometasone (Asmanex, Nasonex), triamcinolone (Aristocort, Aristospan, Clinacort, Kenalog, Nasacort), and others.

This list is not complete and there are many other drugs that can interact with aspirin, butalbital, and caffeine. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

Where can I get more information?

  • Your pharmacist can provide more information about aspirin, butalbital, and caffeine.
  • Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
  • Disclaimer: Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2012 Cerner Multum, Inc. Version: 2.01. Revision Date: 2012-08-09, 5:10:18 PM.

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